83 Validation of a multicenter risk model for implant loss following implant-based reconstruction INTRODUCTION Implant loss is the most severe complication following implant-based breast reconstruction. It has a major impact on the patient’s life, both physically and emotionally.1 Re-operations associated with implant loss may result in a significant decrease in patient satisfaction and in a substantial increase in hospital costs. In addition, it could lead to a delay in further adjuvant treatment.2-6 According to the literature, the occurrence of implant loss varies from 1.8% to 16.9%. Several risk factors for implant loss have been described over the years, including radiotherapy, obesity, smoking, higher age and direct-to-implant (DTI) reconstruction.3, 7, 8 Recently, a risk model to improve patient information and decision making for the type of mastectomy and reconstruction was developed by our study group. However, this model was derived from retrospective data obtained in two medical centers, so the findings may not be generalizable to the reconstructive population at large.9 Therefore, a nationwide population-based cohort with data from the Dutch Breast Implant Registry (DBIR) was used to validate our multicenter risk model for implant loss after implant-based breast reconstructions for mastectomy.10, 11 The aims were to improve patient information on the risk of implant loss and its risk factors, and to improve decision making for the type of mastectomy and reconstruction. METHODS Study design For this nationwide population-based validation study, data were extracted from the Dutch Breast Implant Registry (DBIR), which is a national, prospective, optout registry, with mandatory registration of all breast implant surgery performed in The Netherlands.12 All breast implants (tissue expanders (TE) and permanent implants) used for reconstructive or cosmetic purposes in the Netherlands are registered in the DBIR. The DBIR started in 2015 and all Dutch hospitals performing breast implant reconstructions participate in this registry.12 The multicenter risk model was extracted from our recently published study.9 The study protocol was approved by the scientific committee of the DBIR. No informed consent or ethical approval was required. The study was conducted in accordance with the Declaration of Helsinki and reported according to the strengthening the reporting of observational studies in epidemiology (STROBE) statement.13, 14 Validation cohort Patients who underwent a mastectomy for any reason followed by either a twostage or a DTI breast reconstruction between September 2017 and January 6
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